Contents

How to apply

Prior to submission

You are welcome to contact the VMD to discuss your proposed application. If you wish to arrange a meeting, please email: postmaster@vmd.defra.gsi.gov.uk and include ‘Request to arrange a company meeting’ in the subject line.

You must contact the VMD for advice prior to submission for applications involving veterinary medicines containing or consisting of genetically modified (GM) organisms. A medicinal trial in animals involving the deliberate release of genetically modified organisms into the environment requires both an ATC and consent granted by the Secretary of State for the Environment; a Part B experimental release under Directive 2001/18/EC. The GM Team of Defra is the UK Competent Authority implementing that Directive.

Consent for the Part B release is required before a trial may start. This may take up to 90 calendar days with the addition of any clock stops if information is needed from the applicant so you will need to apply well ahead of the ATC application.

Application Forms

Supporting Data

Do not submit any data or information that have not been asked for; doing so will delay the application process.

The data and documents required in support of an application for an ATC are listed in the application forms.

You must provide an explanation of the purpose of the proposed trial.

Evidence of an ethics committee approval should be provided, if available.

Data to support target animal safety are required for all applications except Type A where there is an existing EU authorisation for the same species using the same indications and dose regimen.

Reference to laboratory efficacy or challenge studies may be necessary.

Applicants may make cross-references to relevant studies in the dossier of an authorised veterinary medicine, which is held by the VMD and to which you have a right of access.

Trials to be conducted under an ATC obtained via a Type B procedure must comply with the latest version of the joint Committee for Proprietary (Human) Medicinal Products / Committee for Veterinary Medicinal Products guideline on, ‘Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products’ – EMEA/410/01. You must provide relevant information including a signed declaration in the appropriate format together with a Certificate of Suitability.

The VMD will not approve trial protocols, except to ensure that safety issues are adequately addressed. The applicant must ensure that the results of trials carried out under ATCs will be appropriate for any subsequent applications for an MA.

Consent form

A blank example owner consent form must be submitted as part of an ATC application.

Informed consent is a documented process by which an owner, or owner’s agent, voluntarily confirms the owner’s willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that are relevant to the decision to participate. The consent form should be in easily understandable language (i.e. minimising and explaining medical jargon) for the owner and include at least the following:

the owner’s consent to the inclusion of their animals into the clinical trial

explanation that the owner understands:

the nature of the trial and the purpose of the treatment

that their animals are participating in a clinical trial using a medicine that has not been authorised or is being used ‘off-label’

if a negative control or placebo is being included that their animal may not receive treatment as part of the trial

they may withdraw their animal from the trial at any time without any prejudice for the future veterinary care of the animal

statement from the vet concerned confirming that if the animal is not responding to treatment that they may treat the animal at any time to maintain appropriate level of veterinary care

confirmation that the owner has fully understood the consent form

Labelling

A package leaflet will be required if there is insufficient space on the label to include all required text.

For already authorised veterinary medicines, you should use the approved labelling, but a small over label should indicate any amended directions or warnings, the ATC number, and the words, ‘Veterinary clinical trial use only’ to ensure accountability in line with GCP requirements.

As a general rule, the VMD will expect labels to contain the following minimum information in English:

the words “For veterinary clinical trial use only”

name or other designation of the product

quantity of product

any restrictions on use

expiry date and, if appropriate, in-use expiry date

directions for use specific to the trial including dosage, frequency, duration, method and route of administration

contra-indications, warnings and precautions, and special instructions for handling and storing the product

instructions for disposal (in most cases, these should state that any unused product and containers should be returned to the trial sponsor)

if to be used in species used to produce food (including horses, rabbits and pigeons) either the specified withdrawal period or the words “Not to be used in animals for human consumption”

name and address of ATC holder and ATC number

the manufacturer’s batch number

a unique code/number identifying the individual container, where appropriate (e.g. where the identity of the products used in the trial are blinded)

For Type A or B procedures you should provide a draft label and package leaflet text with the application.

For Type S procedures you should submit a statement of user and target species safety warnings to appear on the label/leaflet, but otherwise it is your responsibility to ensure that the labelling/leaflets conform to requirements. Additional guidance on the warnings can be found in the annex of the application form.

Validation

It is up to you to identify and submit all the necessary information in support of your application. If the application is incomplete, it is likely to fail validation.

Assessment phase

Once the application has passed validation it will proceed into the assessment phase.

On approval of the application you will be sent a certificate verifying that the trial has been approved and this may be subject to a number of conditions that will be specified on the certificate.

Timescales

The timescales for dealing with ATC applications are as follows:

new Type A/S applications within 30 calendar days of receipt

new Type B applications within 50 clock days of receipt

variations and renewals within 30 calendar days of receipt

ATC Type A, Type S, variations and renewals

Validation

Validated within 5 days of receipt. If the application is incomplete the application will either:

• fail validation and you will be asked to resubmit the application, or • the validation clock will stop and you will be asked to provide the outstanding data. Once received the validation clock returns to 0

Initial assessment

Approved, refused or questions asked by day 15. Whatever the outcome you will be informed.

Applicant response

If questions asked, you should provide a full company response within 10 days from the date of the letter. The clock continues to run during this time. If a response is not received by the deadline the application will be considered withdrawn.

Sign-off

Upon receipt of the response the VMD has up to the end of the 30 day timeframe to assess the response and either approve or refuse the application.

Issue

Following approval, authorisation documentation will be issued within 5 days of assessor sign-off.

ATC Type B

Validation

Validated within 5 days of receipt.If the application is incomplete the application will either:

• fail validation and you will be asked to resubmit the application, or • the validation clock will stop and you will be asked to provide the outstanding data. Once received the validation clock returns to 0

Initial assessment

Approved, refused or questions asked within 35 days. Whatever the outcome you will be informed.

Applicant response

If questions asked the clock will stop pending receipt of your response. You will be asked to provide a response within a given deadline. If a response is not received by the deadline the application will be considered withdrawn.

Sign-off

Upon receipt of the response the clock restarts and the VMD has up to the end of the 50-day timeframe to assess the response and either approve or refuse the application.

Issue

Following approval, authorisation documentation will be issued within 5 days of assessor sign-off.

Fees

Once an application has passed validation, you will be sent an invoice for the fee.

Renewal of an ATC

An ATC is valid for two years. If the trial is not finished within this time frame you may apply to renew the ATC. If an ATC is not renewed by the renewal date it will cease to be valid.

There is no formal application form for renewing an ATC.

Type A and B

You should submit a letter via email requesting renewal of your ATC. The letter should include a justification of why it needs to be renewed, any variations made to the ATC, the ATC number, particulars of the progress of the trial, and a summary account of any adverse events noted.

Type S

You should submit a letter via email requesting renewal of the Type S. The letter should include a justification of why it needs to be renewed and any adverse events noted. Email to: s.response@vmd.defra.gsi.gov.uk.

The timescales for progressing a renewal are the same as those used for a new ATC using a Type A procedure.

Variation of an ATC

Only certain changes may be made by way of a variation (as listed in the application form). All other changes will require submission of a new application; however, where an existing UK trial is being modified, as long as the product formula, species and purpose of the trial remain the same, a Type A procedure will apply.

The timescales for progressing a variation are the same as those used for a new ATC using a Type A procedure.

It is recognised that some tests cannot be set up until an outbreak of a particular disease occurs. In these cases, an ATC may be issued for a maximum number of sites and animals, on the condition that you notify us of the test sites for the exact number of animals included at each site, as soon as they are known. There will be no charge for this.